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. 2025 Sep:158:107961.
doi: 10.1016/j.ijid.2025.107961. Epub 2025 Jun 18.

Switching to bictegravir/emtricitabine/tenofovir alafenamide from efavirenz/emtricitabine/tenofovir disoproxil in virologically suppressed people with HIV: findings from a non-randomized clinical trial (EBONY study)

Roberta Gagliardini  1 , Marta Camici  2 , Simone Lanini  3 , Rita Bellagamba  1 , Sandrine Ottou  1 , Maria Maddalena Plazzi  1 , Alessandra Vergori  1 , Valentina Mazzotta  1 , Annalisa Mondi  1 , Marisa Fusto  1 , Jessica Paulicelli  1 , Massimo Tempestilli  4 , Carmela Pinnetti  1 , Elisabetta Grilli  1 , Ilaria Mastrorosa  1 , Federico De Zottis  1 , Giulia Del Duca  1 , Andrea Antinori  1
Affiliations
Free article

Switching to bictegravir/emtricitabine/tenofovir alafenamide from efavirenz/emtricitabine/tenofovir disoproxil in virologically suppressed people with HIV: findings from a non-randomized clinical trial (EBONY study)

Roberta Gagliardini et al. Int J Infect Dis. 2025 Sep.
Free article

Abstract

Objectives: No previous studies specifically explored the switch from efavirenz to bictegravir (BIC)-containing three-drug antiretroviral regimens. This study aimed to evaluate the efficacy and safety outcomes of a treatment switch from efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) given once daily (OD) or on alternate days (ATAD) to BIC/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in virologically suppressed people with HIV (PWH).

Methods: A pilot, single-arm, prospective study was conducted.

Results: Overall, 234 PWH were enrolled. 217 of 234 (92.7%, 95% confidence interval [CI], 88.6-95.7%) participants had HIV-RNA <40 cp/ml at 48 weeks. Virological failure occurred in three participants, none with documented resistance, and all resuppressed without antiretroviral therapy change. After 48 weeks, a slight increase in cluster of differentiation (CD)4 cell count was observed from the baseline (+ 59 cells/mmc, 95% CI, 31; 86, P <0.001), but not in CD4/CD8 ratio. A slight increase in creatinine (mean change +0.11 mg/dl, 95% CI 0.10; 0.13, P <0.001) and a decrease in total cholesterol (mean change -8 mg/dl, 95% CI -14; -3, P = 0.001) were also observed.

Conclusions: Our data showed that BIC/FTC/TAF demonstrated high virologic and immunologic efficacy and an excellent safety profile.

Keywords: ART optimization; ART-experienced; Antiretroviral therapy; Bictegravir; EFV-based regimen; Integrase strand transfer inhibitor.

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Conflict of interest statement

Declaration of competing interest RG received consultation fees from Gilead, Viiv, and MSD. MC received an institutional grant, support for attending meetings, and speakers’ honoraria from Gilead Science. SL received consultation fees from Gilead, ViiV, and MSD. GDD received an institutional research grant and payments to her institution from Gilead Sciences, speakers’ honoraria, and support for attending meetings and/or travel from ViiV Healthcare and Gilead Sciences. AA has served as a paid consultant to Astra-Zeneca, Gilead Sciences, GlaxoSmithKline, Janssen-Cilag, Merck, Moderna, Mylan, Pfizer, Sharp and Dohme, Roche, Theratotecnologies and ViiV Healthcare and received research institutional grants from Gilead Sciences, Janssen-Cilag and ViiV Healthcare, payment or honoraria from Gilead Science and ViiV Healthcare and support for attending meetings and/or travel from ViiV Healthcare and AbbVie. RB received a grant for speaker’s honoraria/advisory board from ViiV Healthcare, MSD, Janssen-Cilag, and Gilead Sciences. IM received an institutional research grant and support for attending meetings and/or travel from Gilead Sciences. AM received speakers’ honoraria from Gilead Sciences, and ViiV Healthcare, a travel fee from ViiV Healthcare, and participated in advisory boards sponsored by ViiV Healthcare. CP received a personal fee from Gilead Sciences for a case presentation and a travel grant and served on an advisory board for Janssen-Cilag. AV received an institutional grant from Gilead Sciences, speakers’ honoraria/educational activities from Merck Sharp & Dohme and Janssen-Cilag, and served as an adviser for Janssen-Cilag. VM received an institutional grant from Gilead Sciences, and speakers’ honoraria/educational activities from ViiV and Viatris. The other co-authors declare no conflicts of interest for this work.

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